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FDA 510(k)

STERILE CATHERIZATION PROCEDURE TRAYS

K-Number: K830359 · 1983-03-17

ApplicantWelcon, Inc.
Decision Date1983-03-17
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE CATHERIZATION PROCEDURE TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Welcon, Inc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830359. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE CATHERIZATION PROCEDURE TRAYS?

STERILE CATHERIZATION PROCEDURE TRAYS is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Welcon, Inc.. The 510(k) number is K830359.

When did STERILE CATHERIZATION PROCEDURE TRAYS receive FDA 510(k) clearance?

STERILE CATHERIZATION PROCEDURE TRAYS received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830359.

Who is the listed applicant for STERILE CATHERIZATION PROCEDURE TRAYS?

The FDA 510(k) record lists Welcon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE CATHERIZATION PROCEDURE TRAYS?

The FDA product code for STERILE CATHERIZATION PROCEDURE TRAYS is KOD.

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Other records listing Welcon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONK973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATIONK971764WELCON HUE-VU URINARY DRAINAGE BAGK912869WOMEN AND INFANT'S DELIVERY PACKK904158ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAYK894397WELCON LIGHT HANDLE

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Related Devices (Code: KOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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